Dr. Barry Rubin, medical director of the Toronto General Hospital's cardiac centre, and three American co-authors draw the parallel in an article entitled "The 'Liberation Procedure' for Multiple Sclerosis: Sacrificing Science at the Altar of Consumer Demand," in the current issue of the Journal of the American College of Radiology.

Rubin sits on the CIHR's Scientific Expert Working Group, a 23-member international panel created by CIHR in 2010 to monitor and analyse research into the link between MS and chronic cerebrospinal venous insufficiency (CCSVI), a term coined by Italian doctor Paolo Zamboni to describe blockages in the veins of the neck and spine.

Zamboni's so-called "liberation treatment" involves opening the blocked veins by inserting a balloon, a procedure known as venous angioplasty.

Health Minister Leona Aglukkaq announced last month a team of researchers has been selected to conduct a clinical trial into CCSVI in about 100 MS patients.

But the article by Rubin and his three co-authors says funding trials of a procedure "that has minimal basis in rational, empirical knowledge seems questionable." It cites two cases of Canadian MS patients who underwent venous angioplasty.

One died while the other suffered a serious stroke.

The article places Zamboni's therapy in the same category as "treatment of breast cancer with laser photodynamics, Laetrile for cancer and other unproven therapeutics found in the retail sphere. And, it asks, "When is healing 'faith healing?'"

Rubin's views prompted a swift response from Liberal MP Kirsty Duncan, who has pushed for research into the link between CCSVI and MS. In a letter to Alain Beaudet, CIHR's president, Duncan said Rubin "can no longer be seen to be an independent judge of the scientific literature.

"Members of the CCSVI community are concerned that a parallel process is being created — one in which the government says it will undertake clinical trial, while a key player appears to work actively to prevent this," Duncan's letter says.

In an interview, Duncan said Rubin's article, which was not peer reviewed, "clearly shows bias. We want a credible panel. The only way to restore credibility is for him to step down.

"Canadians have to trust this process," she said. " How do you trust this? What's going to be said behind closed doors?"

But in an email to the Ottawa Citizen, Beaudet — who chairs the Scientific Expert Working Group — said members "are entitled to freely express their opinions." The views in the article, he said, "are based on published scientific evidence and solely engage their authors, i.e., neither CIHR nor the working group."

Beaudet also noted Rubin was a member of the working group in 2011 when it recommended that CIHR sponsor trials of Zamboni's procedure.

He added that CIHR is "very much committed to ensuring members of CIHR advisory committees are not in conflict of interest." To that end, all members of the working group signed declarations of conflict of interest last June, he said.

But Duncan said the members of the working group only signed conflict-of-interest declarations after she pushed for it in private correspondence and at public meetings.

Rubin's article is the second bit of bad news this month for advocates of Zamboni's treatment, which has generated much excitement and hope among the estimated 75,000 Canadians with MS.

On May 10, the U.S. Food and Drug Administration issued an alert to doctors and patients warning the liberation procedure had caused death, strokes, abdominal bleeding and nerve damage and there was "no reliable evidence" that it was effective.

More than 12,000 people worldwide — including hundreds of Canadians — have undergone the procedure, but it remains unauthorized and unavailable in Canada.

The researchers selected to conduct the clinical trial into CCSVI in Canada will study the safety of the Zamboni procedure and gather evidence on its effectiveness. First, though, they need to receive ethics approval from the relevant institutional research ethics boards. The study will begin "if and when ethics approval is granted," CIHR said last month.

With about 400 Canadians dying of MS annually, some in the CCSVI community are starting to doubt whether clinical trials will actually proceed in Canada, Duncan said. "The concerns are there."

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